How Do I Become a Medication Technician?

Bai Xianhong, former deputy director of the Social Development Department of the National Science and Technology Commission and director of the China International Science Center, participated in projects with Cuban biomedical science and technology while working in the Ministry of Science and Technology, and led delegations to Cuba to inspect biomedical technology several times. In August 2000, China and Cuba established a joint venture between the two countries in the field of biomedicine, Baitai Biopharmaceutical Co., Ltd., and Bai Xianhong became the company's chairman and general manager.

Be a pioneer of Chinese humanized antibody drugs

Bai Xianhong, former deputy director of the Social Development Department of the National Science and Technology Commission and director of the China International Science Center, participated in projects with Cuban biomedical science and technology while working in the Ministry of Science and Technology, and led delegations to Cuba to inspect biomedical technology several times. In August 2000, China and Cuba established a joint venture between the two countries in the field of biomedicine, Baitai Biopharmaceutical Co., Ltd., and Bai Xianhong became the company's chairman and general manager.

The company's successful Taixinsheng has obvious characteristics in the treatment of advanced malignant gliomas. In 2004, it passed the dual certification of the US FDA and the European Medicines Agency EMA, and was approved as an orphan drug for advanced gliomas. Taixinsheng will be listed in China.

Innovation and development should be enterprise-oriented

Chinese name

Be a pioneer of Chinese humanized antibody drugs

Author

Wang Suping

To source

"Health"

Time

2008-1-29

The executive meeting convened by the State Council not long ago reviewed and approved three national science and technology major implementation plans, one of which is a major new drug creation plan. The program is aimed at the prevention and treatment of major diseases, and develops a group of innovative drugs with independent intellectual property rights. As the boss of a new drug R & D company, how to understand and achieve this goal of the country? What kind of national support did the establishment of Baide Bio-Pharmaceutical Industry have?

China's "Eleventh Five-Year" scientific and technological development plan states that: while establishing a new urban and rural medical service system, we must optimize the industrial structure and promote scientific and technological innovation, focusing on the field of biotechnology, with emphasis on monoclonal antibody drugs, vaccines and diagnostic reagents. Recently, the executive meeting of the State Council proposed that the implementation plan for the major new drug creation special project has the conditions for its implementation, focusing on the prevention and treatment of major diseases, and developing a group of innovative drugs with independent intellectual property rights. This is of great significance for improving the independent innovation capability and industrial competitiveness of China's biomedical companies.

For a long time, independent high-tech drugs in the pharmaceutical field, especially in the biological field, have rarely appeared. Taking monoclonal antibody drugs as an example, the development of the monoclonal antibody drug industry in foreign countries is in full swing. Although China's monoclonal antibody industry has made progress, compared with Europe and the United States, the gap is still large.

At present, most of the monoclonal antibodies developed in developed countries are humanized monoclonal antibodies. Of the 13 monoclonal antibodies approved in China, 7 are imported products. Of the six monoclonal antibodies approved in China, only our company's Taixinsheng is an independent innovative humanized monoclonal antibody drug, and the others are mostly mouse or chimeric antibodies. This is mainly due to insufficient innovation in the source of antibody drugs in China, insufficient antibody reserves, and weak middle and upstream key technologies.

My experience is that the development of innovative drugs must be based on enterprises. In the past, most of the state's input was at the research level, and little attention was paid to the independent innovation of enterprises, resulting in a disconnect between research and development, production and the market. In my opinion, China's biomedical field should take a new path of close integration of production, education, and research. Scientific research institutes are responsible for upstream research and development, and downstream industrial technological innovation must be centered on enterprises. The commercialization of new drugs is not a simple technology transfer. It must be supported by downstream industrialization technology. Taking monoclonal antibody drugs as an example, there are huge technical barriers to industrialization. Only through technological innovation by enterprises can the industrialization of products be achieved.

China is also making efforts in this regard. The establishment of Biotech Biopharma has obtained key national support, including the support of the Ministry of Science and Technology of China's High-Tech Research and Development Program (863 Program) and the National Development and Reform Commission's "High-Tech Industrialization Demonstration Project" "stand by.

Reporter: What is the technological content of Tai Xinsheng's molecular targeted therapy for malignant solid tumors?

Taixinsheng is a high-tech biopharmaceutical developed by the comprehensive use of modern biotechnology such as genetic engineering, antibody engineering, and cell engineering. It is a specific monoclonal antibody directed against epidermal growth factor receptor (EGFR) overexpressed in tumor cells. , Is also the world's first monoclonal antibody drug against EGFR, China's first humanized monoclonal antibody.

Murine monoclonal antibodies and chimeric monoclonal antibodies, due to their strong immunogenicity, often cause immune responses in the human body, with obvious toxic and side effects, which greatly restrict their development in clinical applications. Antibody humanization technology converts most of the mouse-derived monoclonal antibodies into human components, thereby eliminating the human immune system's rejection response to exogenous monoclonal antibodies.

Through international cooperation, Baxter Biopharmaceutical took the lead in establishing the first world-leading antibody humanization technology platform in China, using advanced "CDR transplantation" technology to develop a monoclonal antibody with a humanization level of 95% The drug Taixinsheng has reduced the incidence of HAMA (human anti-mouse antibody) reactions in clinical applications.

However, we also need to see that the gap between China s monoclonal antibody industry and European and American companies is large. At present, the annual mammalian cell culture volume in European and American countries reaches 4 million liters, compared with 3,000 liters in China. / Year, China is only 10 kilograms.

Why choose to cooperate with Cuba

Generally, Sino-foreign joint ventures are joint ventures with developed countries in Europe and the United States. Why did Baitai Biopharma choose Cuba?

According to common sense, when looking for partners in the field of antibody drugs, the preferred target should be the US antibody industry or scientific research institution that has a leading advantage in the industry. However, at that time, we did not have any conditions to conduct substantial exchanges and technology transfers with the US antibody industry, and it was impossible for the "enterprise aircraft carriers" of global antibody drugs to bring their latest and most competitive antibody drug research results, Technology and a complete industrial system have been transferred to China-because antibody drugs and antibody engineering systems are one of the commanding heights of fierce competition in the field of biotechnology in countries around the world today.

In this case, after a lot of research, Cuba's novel biotechnology achievements have entered our field of vision. Cuba is a developing country with a fairly advanced level of biomedical technology and medical treatment. Especially in the field of antibody drugs, the Cuban Molecular Immunization Center (CIM) has achieved remarkable results, which are even of interest to the United States. Although there is no economic exchange between the United States and Cuba, in July 2006 the United States specifically approved the introduction of new antibody drugs from Cuba to conduct clinical research on anti-glioma in the United States. China and Cuba share common backgrounds and development needs, and both sides can actively expand cooperation in the economic and technological fields.

In 1998, we signed an intellectual property agreement and a cooperative development agreement with the Cuban CIM, which legally defined the responsibilities, obligations, powers, and interests of the two partners, and based on this, established a Sino-Cuban joint venture in the Beijing Economic and Technological Development Zone. Biotech Enterprise-Baitai Biopharmaceutical Co., Ltd. The company owns the intellectual property rights of Taixinsheng in China and the independent industrial technological property rights of large-scale mammalian cell culture drug production. With the joint efforts of the ancient experts, Biotec Biopharmaceuticals is the first in China to achieve large-scale mammalian cell culture. We plan to achieve 50 kg / year of monoclonal antibody production by 2010. We must do everything possible to reduce costs and make them affordable for cancer patients. Our drugs.

No. Name Company Antibody Type Therapy Area

1 Anti-CD3 mAb / Ioshan Cuban Molecular Immunology Center

2 Rituximab / Merovar Roche / Gene Tektronix Chimeric Non-Hodgkin's Lymphoma

3 Trastuzumab / Herceptin Roche / Gene Tek Humanized Breast Cancer

4 Muromonab-CD3 Anti-Rejection Therapy in Rat Organ Transplantation

5 Daclizumab / Xenipirox / Genentech Anti-Rejection Therapy for Humanized Organ Transplantation

6 Basiliximab / Sulova Novartis Anti-Rejection Therapy for Chimeric Organ Transplantation

7 Anti-CD3 monoclonal antibody anti-rejection treatment of rat organ transplantation in Wuhan Institute of Biological Products

8 Anti-human il-8 monoclonal antibody cream / Enbok Hongyuan Yishi Biotechnology Pharmaceutical Co., Ltd. Mouse-derived psoriasis

9 Cetuximab / Erbitux Merck / Inclon Chimeric Colorectal Cancer

10 Nimotuzumab / Taixin Shengbaitai Biopharmaceutical Co., Ltd.Humanized head and neck tumors, digestive tract tumors

11 Iodine [131I] Human-mouse chimeric Meien Biotechnology Co., Ltd. Chimeric lung cancer

Tumor cell nuclear mAb / Aesthetic

12 Iodine [131I] Metuximab / Ricatin 4th Military Medical University / Chengdu Huashen Group Mouse-derived liver cancer

13 Recombinant human type II tumor necrosis due to recipient Humanized rheumatoid arthritis of Shanghai CITIC Guojian Pharmaceutical Co., Ltd.

Antibody fusion protein